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Enlarger™

EUDAMED

Class I (EU MDR)

Ref 192030SModel 191020SRef 193030SRef 193030Ref 192020S

by APT Medical Inc.

Identity

Trade Name
Enlarger™ EUDAMED
Device Name
Enlarger™ Inflation Device EUDAMED
Model / Reference
191020S EUDAMED
192030S EUDAMED
193030S EUDAMED
193030 EUDAMED
192020S EUDAMED

Identifiers

Primary DI / UDI-DI
06949450411841 EUDAMED
06949450411834 EUDAMED
06949450413036 EUDAMED
06949450413043 EUDAMED
06949450411865 EUDAMED
Basic UDI-DI
69494504IFD19R6 EUDAMED
EMDN Code
C01040180 CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Enlarger™ by APT Medical Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
APT Medical Inc.
EUDAMED SRN
CN-MF-000009046
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (5)

  • EUDAMED f1689fbc-356f-47e6-be45-00e1b553a756 61 fields · synced Aug 4, 2026
  • EUDAMED 4fa76a85-61e2-4ce2-952a-a4a5d7c94e0c 61 fields · synced May 17, 2026
  • EUDAMED 6250507e-cc11-40e6-9379-2f45f39ba4da 61 fields · synced May 17, 2026
  • EUDAMED f4733235-c503-486a-8696-221e70e60691 61 fields · synced May 17, 2026
  • EUDAMED 96db90d9-c3fd-4fb5-abec-3307844d5c59 61 fields · synced May 19, 2026